MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM QUATTRO CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-4593
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since there were no device deficiencies reported by the site, the device associated with this complaint will not be returned to zoll for physical evaluation.Based on the information provided by the site, there were no device deficiencies reported.This patient had a medical history of multiple conditions including hypertension, dyslipidemia, diabetes, renal dysfunction, obesity, and hypothyroidism.The patient experienced cardiac arrest, was resuscitated, admitted to the hospital, enrolled in the study, and underwent cooling procedure.11 days post catheter removal, clinically non-significant sub-segmentary thromboembolism was diagnosed by a computed tomographic pulmonary angiography.The patient did not experienced any clinical symptoms.The site reported that the event was not serious, related to the patient's clinical condition, and not related to study device or study procedure.The multi-row detector ctpa is highly sensitive and specific for pe, including the relatively smaller emboli confined to subsegmental pulmonary arteries.A recent systematic review has suggested that this improved detection of subsegmental pe represents overdiagnosis of relatively unimportant emboli for which the risks of anticoagulant therapy may not be warranted.However.Most of authors agree that for now, pe, including subsegmental pe, should be considered a serious and unforgiving condition for which the benefits of contemporary anticoagulant therapy outweigh the risks for most patients.Asymptomatic or silent pulmonary embolism (s-pe) in patients with deep vein thrombosis has been the focus of numerous publications.The objective was to determine the incidence of s-pe and to assess whether the existence of s-pe has any clinical or therapeutic consequences that outweigh the risks associated with the diagnostic tests performed and the increased healthcare costs.A prospective and consecutive assessment of 103 hospitalized patients with lower limb dvt in the absence of pe symptoms, using ct scan, and three-year follow-up assessing risk recurrence and clinical outcome was performed.No significant recurrence rate of thrombotic events was observed in the s-pe group during the follow-up.The incidence of s-pe in lower-limb dvt is high, but in the absence of symptoms, diagnosis does not appear to be necessary, as there are no short - or long-term clinical or therapeutic consequences (1).The authors discuss the uncertain clinical significance of subsegmental pe, suggesting that the prognosis is associated more with the presence of accompanying disorders than the extent of the disease.Although there have been many advances in the management of pe, a number of justifiable doubts persist.(1.García-fuster mj, fabia mj, furió e, pichler g, redon j, forner mj, martínez f.Should we look for silent pulmonary embolism in patients with deep venous thrombosis? bmc cardiovasc disord.2014 dec 8; 14:178.Doi: 10.1186/1471-2261-14-178.).Catheter related thrombosis is a known complication with intra-vascular catheter use of any kind.Although, it is unknown if the thrombus is related to zoll catheter, the event could be probably attributed to use of the device.Per zoll labeling, possible complications with central venous catheters include thrombosis.
Event or Problem Description
A (b)(6) male was enrolled in the (b)(6) study on (b)(6) 2015 at 17:23 with a past medical history of hypertension, dyslipidemia, diabetes, renal dysfunction, obesity, and hypothyroidism.The patient was a current tobacco user and formerly alcohol user.On (b)(6) 2015 the patient had a witnessed out of office cardiac arrest at 15:32.Before ems arrival, he received bystander chest compressions and ventilation at 15:32.Ems arrived at 15:42, the patient was treated with cpr and defibrillation.Rosc was achieved at 15:45 with initial rhythm of ventricular fibrillation.The patient was intubated.At admission, a pulse rate of 63 bpm, bp of 99/79 mm hg, and respiratory rate of 18 breaths per min were recorded.On the same day, on (b)(6) 2015 at 19:00, ivtm quattro catheter was inserted into the right femoral vein successfully and cooling was initiated.Re-warming was initiated on (b)(6) 2015 at 01:00.Catheter was removed on (b)(6) 2015 at 19:00.On (b)(6) 2015 at 12:00, 16 days post initiation of cooling procedure, 14 days post re-warming procedure, and 11 days post catheter removal, clinically non-significant sub-segmentary thromboembolism was diagnosed by a computed tomographic pulmonary angiography.The patient did not experienced any clinical symptoms.The patient was treated with medications and the event was resolved without sequelae on the same day at 13:00.On (b)(6) 2016, 72 days post enrollment, he was discharged from the hospital to long term skilled nursing facility in stable condition.On (b)(6) 2016, the patient completed 1 year follow up successfully.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6296770
• Report Number: 3010617000-2017-00086
• Device Sequence Number: 10861628
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IC-4593
• Device Catalogue Number: 8700-0660-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 58 YR